Heart, Vessel, Blood

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The Heart, Vessel, Blood (HVB) CTSU enhances the performance of cardiovascular, coagulation, and nonmalignant hematologic clinical trials, including specializing in device trials and drug trials across the lifespan of acute and chronic disease. The CTSU offers specialty recruitment services, quality assurance, and junior faculty support.

The HVB CTSU includes a coordinator team designed to serve junior faculty as well as established study teams on an as-needed basis. The coordinator team is available to prepare IRB submissions and provide full coordination of any CTSU clinical trial. The HVB CTSU provides pre- and post-award support for industry, NIH, and investigator-initiated trials along with mentorship throughout this process.

The Cardiovascular Center Clinical Research Group (C3RG) is a successful resource that the HVB partners with to continue providing training and resources to clinical researchers across the U-M community. The Cardiovascular Center Research Recruitment Coordinator position facilitates cross-communication and increases overall clinical trial enrollment as well as maintains a catalog of clinical trials. This position provides potential study volunteers with a point person who can triage questions and provide information about clinical trials within the CTSU with the goal to create awareness of all research opportunities available.

The HVB Transformation Team was created as a forum to communicate initiatives and workflows of the CTSU and how these relate in the transition of work for study coordinators along with a partnership to look at existing and new practices.  The team consists of representatives from various groups of the CVC along with HVB Research staff. The HVB CTSU also offers a “facts and snacks” focused seminar series with the purpose of discussing how U-M's clinical trial management system, OnCore and CTSU driven workflows are integrated into study coordinators daily tasks.

IS YOUR STUDY A CLINICAL TRIAL?

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Correctly identifying whether your study is a clinical trial is crucial in complying with NIH policies and Michigan Medicine.

If you answer yes to the following questions, then your study qualifies as a clinical trial:

  • Does the study involve one or more human subjects?
  • Does the study involve the use of one or more interventions?
  • Does the study prospectively assign human subject(s) to an intervention(s)?
  • Does the study have a health-related biomedical or behavioral outcome(s)?

Learn more about the NIH Clinical Trial Definition at nih.gov.

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HOW WE SERVE YOUR CLINICAL TRIAL NEEDS

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Feasibility Review Support
The Feasibility Review, conducted by the appropriate CTSU, looks at the whole picture of a potential clinical trial to prevent unexpected challenges in its execution and to open to accrual in a timely manner. LEARN MORE.

 

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Pre-/Post-Award Support
Clinical Trials Support Units keep studies on track during the pre- and post-award process. A CTSU portfolio manager follows a study along its lifecycle and assists teams on their path to study activation. LEARN MORE.



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Study Coordinator Support
Principal Investigators can ultimately find a smoother process and save time by taking advantage of our study coordinator pool, which can provide investigators with team members who are already on staff and fully trained. LEARN MORE.
 

METRICS

168 HVB Studies          60 HVB Principal Investigators          2576 HVB Subjects

FACULTY AND STAFF

Medical Director

Keith Aaronson, M.D.

Portfolio Manager

Heather Golden, goldenh@med.umich.edu, 734-998-7636

 

 

Questions?

Contact us at CTSU.HeartVesselBlood@umich.edu

MBNI Building, 205 Zina Pitcher Place, Ann Arbor, MI 48105

A list of HVB CTSU contacts are available in the Personnel Directory.